Neural monitoring and / or stimulation electrode assemblies

Abstract

A stimulation and recording electrode assembly particularly suitable for automatic periodic stimulation (APS). Such embodiments are compatible with nerve monitoring systems to provide continuous stimulation of nerves during surgical procedures. Certain embodiments include an electrode assembly having a cuff, the cuff comprising a body and two ear handles extending from the body. Within the body, at least one electrode is supported and connected to a lead assembly. The ear handles can be brought together to expand the gap in the body so that the electrode assembly can be fixed around the nerve. Other embodiments include an electrode assembly, the electrode assembly comprising a first and a second needle electrode, each having a tip. A body is provided to interconnect the needle electrodes and the body can be manipulated to move the tips toward or away from each other. The disclosed embodiments provide nerve monitoring and stimulation in cases where the nerve is only partially dissected.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of the filing date of U.S. Application No. 15 / 907,980, filed on February 28, 2018, the entire teachings of which are incorporated herein by reference. Background Art

[0003] Use of neuromonitoring during surgical procedures where nerves are at risk. With some systems, the monitor and handheld stimulator probe provide intermittent stimulation only when the surgeon probes the nerve with the probe. However, nerves may be at risk between stimulations due to trauma from “blind” surgical incisions caused by manipulation and stretching during tumor resection and cumulative trauma or injury that may lead to neuropraxia. However, automated periodic stimulation (APS) provides continuous intraoperative neuromonitoring (C-IONM). Intraoperative nerve integrity monitoring (NIM) systems enable surgeons to identify, confirm and monitor motor nerve function to help reduce the risk of nerve injury during a variety of procedures including ENT and general surgery.

[0004] One such system is the Medtronic A neuromonitoring system that includes an electromyography (EMG) monitor for intraoperative use during various surgical procedures where nerves may be at risk due to accidental manipulation. A NIM neuromonitoring probe with electrodes is placed in the patient's body at the appropriate muscle sites for the procedure being performed. These electrodes are connected to the NIM neuromonitoring system, which continuously monitors EMG activity from the muscles innervated by the affected nerves. The NIM system alerts the surgeon and operating room staff when a specific nerve has been activated or stimulated, providing visual warnings on a color touch screen monitor and audio feedback to help minimize trauma to the nerve.

[0005] Surgeons can use The NeuroMonitoring System's monopolar and bipolar stimulating probes and dissecting instruments assist in early nerve identification and confirmation. These tools can be used to locate, identify, and map specific nerves and branches, as well as verify nerve function and integrity to help surgeons perform critical procedures while preserving nerve function and improving patient safety.

[0006] The present disclosure provides improvements associated with the related art. Summary of the invention

[0007] Aspects of the present disclosure relate to stimulation and recording electrode assemblies that are particularly suitable for continuous intraoperative neuromonitoring (CIONM), automatic periodic stimulation (APS), or therapeutic stimulation. Such embodiments are compatible with neuromonitoring systems to provide continuous stimulation of nerves during surgical procedures where the nerves are at risk. Examples of surgical procedures for which the disclosed embodiments are particularly suitable include facial nerve, parotidectomy, thyroidectomy, endoscopic, and lateral skull base surgeries.

[0008] The disclosed embodiments include an electrode assembly having an electrode supported by and positioned within a deformable cuff. In one illustrative embodiment, the cuff includes a body having a first end, a second end and defining a first channel configured to receive the nerve. The cuff further includes first and second ears extending radially outward from the body. A second channel is formed in the first ear for accommodating and supporting an electrode. The body may additionally maintain a second electrode for bipolar applications. The body defines a gap, and the width of the gap is variable and configured to support a fixed angle of the nerve of less than 360 degrees. In other words, the embodiments of the present disclosure are suitable for use with partially dissected nerves. A lead assembly is interconnected with each electrode and extends through the second channel. In use, the ears can be squeezed together to allow an operator to expand the gap in the cuff to place the cuff at least partially around the nerve. In this way, the electrode assembly is maintained in a suitable position wrapped around the nerve.

[0009] Various other disclosed embodiments include a self-retaining needle electrode assembly that also allows for minimal neuroanatomy to be placed in place. The electrode assembly may include first and second needle electrodes; wherein the first needle electrode includes a first tip and the second needle electrode includes a second tip. The electrode assembly further includes a body interconnected to the first and second needle electrodes and having a first end, a second end, a first side portion, and a second side portion. The body includes an elastic hinged section interconnected to the first and second side portions. The body has an inherent arrangement, and the body also has an expanded arrangement, wherein the first and second side portions are drawn together at the second end so that the first and second tips are positioned further away from each other than in the inherent arrangement. A lead assembly interconnected to the first and second electrodes is also provided. The self-retaining needle electrode assembly may be particularly suitable for stimulation and recording of muscles (e.g., cricothyroid muscle), for example, in thyroid surgery.

[0010] The disclosed embodiments provide for continuous intraoperative monitoring and / or therapeutic stimulation in current and new procedures without requiring additional dissection or necessary wrapping of the electrode assembly around the entire corresponding nerve. Various disclosed embodiments are configured for use with partially dissected nerves, where the circumference of the partially dissected nerve is less than the entire circumference of the exposed nerve (e.g., 50%). For many procedures, the procedure itself requires 50% or more of the nerve dissection, and therefore, additional dissection is generally not required to place the disclosed electrode assembly in the appropriate position for use. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 is a perspective view of one embodiment of an electrode assembly.

[0012] Figure 2 yes Figure 1 A partial enlarged view of the electrode assembly.

[0013] Figure 3A It is arranged in a fixed way Figure 1 Front view of the electrode assembly.

[0014] Figure 3B is a front view of the electrode assembly in an expanded arrangement.

[0015] Figure 4 The electrode and lead assembly is shown in FIG. Figure 1 A partial enlarged cross-sectional view of an electrode assembly.

[0016] Figure 5A-5B Shows Figure 4 of electrodes.

[0017] Fig. 6A yes Figure 1 and 4 A perspective view of the lead assembly.

[0018] Figure 6B yes Fig. 6A A partial enlarged view of the inner sheath and wire core of the lead assembly.

[0019] Figure 7 is similar to Figure 6A-6B Cross-sectional view of the lead assembly interconnecting the suspension retaining clip and protected pin socket.

[0020] Figure 8 is a cross-sectional view of an alternative electrode assembly.

[0021] Fig. 9 yes Figure 8 Figure 2. Perspective view of the electrode assembly placed on an anatomical nerve.

[0022] Fig.10 yes Figure 8-9Perspective view of the electrode assembly placed on a partially dissected nerve.

[0023] Fig.11A is a bottom view of an alternative electrode assembly.

[0024] Fig. 11B yes Fig.11A A perspective view of an alternative electrode assembly.

[0025] Fig. 12A is a perspective view of an alternative electrode assembly that is generally similar to the previously shown embodiment, but wherein the electrode assembly includes two electrodes.

[0026] Fig. 12B yes Fig. 12B Cross-sectional view of an electrode assembly.

[0027] Fig.13A is a plan view of a self-retaining needle electrode assembly in a native arrangement.

[0028] Fig. 13B is a plan view of a self-retaining needle electrode assembly in a deployed arrangement.

[0029] Fig.14A yes Figures 13A-13B Perspective view of a self-retaining needle electrode assembly dissected close to nerve tissue.

[0030] Fig. 14B yes Fig.14A Side view of a self-retaining needle electrode assembly operably positioned within tissue proximate a nerve. DETAILED DESCRIPTION

[0031] Neuromonitoring is used during surgical procedures where nerves are at risk. Monitors and handheld stimulator probes with electrodes provide intermittent stimulation only when the surgeon probes the nerve with the probe. However, nerves may be at risk between stimulations due to the trauma of the surgical incision "blind" caused by manipulation and stretching during tumor resection, and cumulative trauma or damage that may lead to neuropraxia. However, automatic periodic stimulation (APS) provides continuous intraoperative neuromonitoring (C-IONM). The electrodes continuously and periodically stimulate the nerve to provide amplitude and latency trends in real time, which include adjustable alarm limits for significant baseline changes. This early warning helps alert the surgeon to stop surgical trauma, as most injuries are immediately reversible but may become permanent if prolonged.

[0032] Various aspects of the present disclosure relate to stimulation and recording electrode assemblies particularly suitable for use with APS. Such embodiments are compatible with neuromonitoring systems to provide continuous neurostimulation during surgical procedures. Two such compatible neuromonitoring systems include NIM- 3.0 and NIM- 3.0 Nerve Monitoring System, both available from Medtronic, Inc., Minneapolis, Minnesota. The disclosed electrode assembly is particularly suitable for monitoring the facial nerve at the main trunk during head and neck surgery, and for monitoring the facial nerve during lateral skull base surgery (LSB). The electrodes can be used for short surgeries of less than 24 hours, or can be implanted in the patient for more than 24 hours. The electrode surface can be coated to deliver drugs during contact or enhanced treatment, such as by electroplegia. However, the use of the disclosed embodiments is not intended to be limited to those specific surgeries. For example, it is also contemplated that the disclosed embodiments are suitable for use in stimulation therapy surgeries. In one illustrative example, treatment can be achieved by applying electrical stimulation to the nerve at a stimulation rate of about 20 Hz.

[0033] Figure 1-7 An example embodiment of an electrode assembly 10 is shown in FIG. The electrode assembly 10 includes an evoked potential monitoring electrode 12, which is supported by and positioned within a cuff 14, the cuff including a body 16 having two parallel ends 18a, 18b. The body 16 further defines a channel 20 in which a nerve can be positioned. As shown, the body 16 can have a semicircular cross-section (typically C-shaped) at the first end 18a and the second end 18b and / or throughout the body along the channel 20. Extending radially from the body are two ears or lugs 22, 24. In some embodiments, each ear handle 22, 24 can include a textured surface 26, 28 (e.g., ridges), which can assist in grasping the ear handle 22, 24 (in FIG. 2 ), for example, using a surgical instrument that can be a clamp. Figure 3A-3B Schematically depicted in FIG. Figure 3A-3B As shown in , the cuff 14 includes an open and closed position, wherein the width W1 of the gap 36 formed by the body 16 and the width W2 of the channel 20 of the body 16 are changed via the flexion of the cuff 14 at the hinge section 38. The ears 22, 24 can be squeezed or moved with the surgical instrument so that the hinge section 38 of the body 16 positioned between the ears 22, 24 flexes and extends the width W1 of the gap 36 and the width W2 of the channel 20 so that tissue and / or nerves can be excavated or otherwise positioned within the channel 20 of the body 16. Once the instrument releases the ears 22, 24, the cuff 14 transitions back to the closed position due to the elastic nature of the body 16. Figure 3A The location of Figure 3BIn comparison, gap 36 has a reduced width W1 and channel 20 has a reduced width W2. Suitable materials for ferrule 14 include, but are not limited to, NuSil MED-4980 silicone rubber available from Nusil Technology LLC of Carpinteria, California, NuSil MED4980 silicone rubber containing 25% NuSil MED2-4900 and optionally 2% colorant (both available from Nusil Technology LLC), C- TPE, R70-095-000Shore65A, or similar elastomeric materials.

[0034] In one embodiment, the gap 36 is positioned opposite (approximately 180 degrees) the articulation section 38. In some embodiments, the gap 36 is positioned at a circumferential distance from each ear handle 22, 24, and the distance is equal on the first end 18a and the second end 18b of the body 16. The gap 36 can be linear, extending from the first end 18a to the second end 18b parallel to the central axis A of the channel 20, or configured in other ways and provide continuous intraoperative monitoring and / or therapeutic stimulation in current and new surgeries that put nerves at risk without requiring additional dissection or necessary wrapping of the electrode assembly 10 substantially around the entire circumference (i.e., 360 degrees) of the corresponding nerve (because a complete dissection of the nerve is required). Various disclosed embodiments are configured for use with partially dissected nerves, wherein at least about 50% or more of the circumference of the nerve is exposed. Although embodiments of the present invention can be used for fully dissected nerves in which 100% of the circumference of the nerve is exposed, any degree of dissection greater than about 50% of the circumference is suitable. For many surgeries, the surgery itself requires this degree of nerve dissection, and therefore, additional dissection is generally not required to place the electrode assembly of the present invention in the appropriate position for use. In various embodiments, the body 16 is configured to connect to the nerve in the range of about 1 to about 4 mm. Therefore, in such embodiments, when fixed around the nerve, the width W2 of the channel 20 is in the range of about 1 mm to about 4 mm. One or more elements of the electrode assembly 10 may optionally include a pigment to provide color differences between various body sizes and / or to distinguish the electrode assembly from the patient's anatomy.

[0035] It may be best to Figure 4As shown, the electrode 12 can be supported in a channel 50 formed in one of the ear handles 22. The channel 50 can have a variety of configurations. One example configuration includes a first portion 52 of the shaft 40 for receiving and holding the electrode 12. The first portion 52 is connected to a second portion 54, which receives the top 42 of the electrode 12 and at least a portion of the lead assembly 60. As will be described in more detail below, the lead assembly 60 includes at least one insulating sheath 62 positioned around a core 66.

[0036] Electrode 12 can be used as recording and stimulation electrode and therapeutic stimulation electrode. In some embodiments, as described below with respect to Figures 12A-12B As further disclosed, two electrodes may be provided to provide bipolar stimulation or recording, and the two electrodes are configured to communicate electrical stimulation to the tissue, and therefore must provide an appropriate surface area of ​​contact with the tissue for current density. The material forming the electrode 12 or the surface treatment (not shown) provided on the electrode 12 at the base 44 (or the interface where the electrode 12 contacts the nerve) may be selected to enhance the bioelectric interface with the tissue via selection of such preferred base metals, sintering to increase the surface area, or electroplating. Examples of suitable materials for the electrode 12 at the interface or base 44 include stainless steel, copper, gold, iridium, palladium, platinum, rubidium, ruthenium, silver, conductive plastics, or inks. Conductive plastics or inks may be used on the surface of the top 42 or base 44 to enhance conductive delivery to the tissue. For example, the conductive ink may have about 40% to 60% conductive silver particles and polyvinyl chloride (PVC) particles, wherein the PVC particles have a solvent that evaporates to dry the ink on the surface of the electrode 12. Conductive plastics constructed of conductive particles and polymeric particles are melted together to form conductive plastics.

[0037] Best as Figure 4-5BAs shown, the electrode 12 can be configured to allow crimping and strain relief of the lead assembly 60. The electrode 12 includes a shaft 40, a top 42, and a base 44. Such features correspond to the features of the channel 50, so that the electrode 12 is generally immovable relative to the channel 50. In addition, the top 42 can include a dome-shaped portion 46, which is interconnected with a flange portion 48 extending outwardly relative to the dome-shaped portion 46 and the shaft 40. The top 42 includes a first channel 49a and a second channel 49b configured to hold a portion of the lead assembly 60. In one embodiment, the first channel 49a is positioned within the dome-shaped portion 46 and can be crimped to the exposed wire core 66 near the top 42 using a single point crimp. The second channel 49b can be used to provide strain relief within the wire core 66 and can be optionally positioned to extend within the flange portion 48. In certain embodiments, the top 42 is configured to provide a low-profile wire core 66 interface. In the illustrated embodiment, the first channel 49a is configured to hold the sheath 62 and the core 66, and the second channel 49b is configured to hold only the core 66. The electrode 12 can be made of a material compatible with an adhesive, or can otherwise provide a surface compatible with an adhesive, so that the core 66 can be secured to the top 42 of the electrode 12 using an adhesive (not shown).

[0038] Although not shown, the electrode 12 may optionally be selectively electrically insulated. In such embodiments, the electrode 12 may be completely coated with an insulator (e.g., using chemical vapor deposition). This coating may then be selectively removed (e.g., using a laser) to expose desired areas. Alternatively, the electrode 12 may be masked, and then an insulating coating may be applied.

[0039] As in Figure 1 As can be seen in the figure, the lead assembly 60 can optionally further include a sleeve 63. The sleeve 63 can be made of a material such as cotton, which allows the clinician to stick the lead assembly 60 to a portion of the patient's anatomical structure (not shown). In such embodiments, the sleeve 63 can optionally slide along the length a of the sheath 62 so that the sleeve 63 can be selectively positioned along a portion of the sheath 62, wetted with water or the like, and then pressed onto the anatomical structure to facilitate the adhesion of the sleeve 63 to (and therefore the adhesion of the lead assembly 60 to) the anatomical structure.

[0040] Now turn to Figure 6A-6B, which shows a lead assembly 60. The lead assembly 60 may include a single insulating sheath or may include an inner sheath 62a and an outer sheath 62b that insulate the wire core 66. In an embodiment in which an inner sheath 62a and an outer sheath 62b are provided, the outer sheath 62b may be at least partially stripped from the inner sheath 62a to eliminate the need to potentially splice the lead assembly 60. In addition, a release agent 68 such as silicone may be applied between the inner sheath 62a and the outer sheath 62b to prevent adhesion between the inner sheath 62a and the outer sheath 62b. In some embodiments, a length L of about 6 inches of the inner sheath 62a will be exposed relative to the outer sheath 62b.

[0041] The lead assembly 60 is ductile and bendable, having flexibility similar to that of a thread while having high tensile strength. Where provided, the inner sheath 62a and the outer sheath 62b (or a single sheath) provide electrical insulation for the core 66, and in some embodiments, one of the inner sheath 62a and the outer sheath 62b or both are thin to maintain the flexibility of the lead assembly 60 or the sheath 62a / 62b. In an exemplary embodiment, the sheath or outer sheath 62b is made of a low reflective material such as polyvinyl chloride (PVC) and provides electrical insulation of 1000VC dielectric strength. Where provided, the inner sheath 62a may be made of polytetrafluoroethylene (PTFE), for example. The core 66 is ductile to maintain a deformed shape and may optionally be made of a 300 series stainless steel 40AWG single strand material. The sheaths 62a, 62b may optionally have a specific color, such as yellow, to contrast with the patient's anatomy. As described with respect to Figure 7 As shown in the lead assembly 60 in FIG. 1 , the lead assembly 60 may further support electrical connection with the electrode 12 and / or APS system (not shown) via a pin socket 70 that provides electrical communication with a patient interface (not shown). The pin socket 70 may be protected according to the compliance of the International Electrotechnical Commission 60601.

[0042] like Figure 7 As generally shown in FIG. 1 , a retaining clip 80 can be secured to a lead assembly 60 to secure the lead assembly 60 to a patient's ear / nose or to a sterile drape covering the patient during a surgical procedure, for example, to provide strain relief within the lead assembly 60. The retaining clip 80 can be configured to include two arms 82, 84, the arms including an articulated connection 86 biased in a closed position. The articulated connection 86 can include a pin around which the two arms 82, 84 can rotate. The two arms 82, 84 can be spring biased to a closed position. The retaining clip 80 includes a mounting block 88 that secures one arm 82 to the sheath 22b. The mounting block 88 can be configured to allow the retaining clip 80 to slide along the length of the lead assembly 60 under light resistance (e.g., 0.3 lbs or less). In addition, the mounting block 88 can be connected to the retaining clip 80 so as to allow the retaining clip 80 to rotate or spin 360 degrees relative to the mounting block 88.

[0043] The ferrule 14 can have a variety of configurations. Figure 8-10 1 shows an electrode assembly 110 with an alternative ferrule 114. In this embodiment, the ferrule 114 includes ears 122, 124 positioned on either side of the hinge section 128, the ears 122, 124 each having a corresponding leg 130, 132. In this embodiment, one ear 122 includes a channel 150 to maintain the electrode 12 and at least a portion of the lead assembly 60. Optionally, the channel 150 may include a conical lead in feature 156 to make it easier to screw the lead assembly 60 to the electrode 12. Fig. 9 The electrode assembly 110 is shown to achieve a 360 degree anatomy of the nerve N, and Fig.10 The electrode assembly 110 is shown to achieve less than 360 degrees (and greater than 180 degrees) of dissection of the nerve N. As will be apparent in view of this disclosure, the electrode assembly 110 may otherwise be identically configured and function the same as the previously described embodiments.

[0044] Figures 11A-11B 2 shows another embodiment of an electrode assembly 210. This electrode assembly 210 includes a cuff 214 having a body 216 defining a channel 220 and two ears or lugs 222, 224 extending radially outward from the body 216. As in the previous embodiment, the ears 222, 224 are positioned on either side of an elastic hinge section 238, the configuration and operation of which are similar to the hinge sections previously described. In some embodiments, one or more ears 222 may include a textured surface 226, which, for example, includes ridges or legs 232. In this embodiment, the two ears 222, 224 are not configured identically. In addition, the gap 236 formed by the body 216 of the cuff 214 is non-linear and generally wavy, which is beneficial for small diameter nerves that can potentially slide through the gap 236 if the gap is linear. Other non-linear shapes of gaps are contemplated. The configuration and function of this electrode assembly 210 may be the same as those previously described in all other aspects.

[0045] Figures 12A-12BYet another embodiment is shown in FIG. Electrode assembly 310 includes two electrodes 312a, 312b of the previously disclosed type, which are supported and positioned in the cuff by a cuff 314, and the cuff includes a body 316 having two parallel ends 318a, 318b. The body 316 further defines a channel 320 in which a nerve can be positioned. As shown, the body 316 may have a semicircular cross-section (usually C-shaped) at the first end 318a and the second end 318b and / or along the channel 320 throughout the body 316. Extending radially from the body are two ear handles or lugs 322, 324. The ear handles 322, 324 can be configured as described with respect to the previous embodiment. Similar to the previous embodiment, the cuff 314 includes an open and closed position, wherein the width of the gap 336 formed by the body 316 and the channel 320 of the body 316 is variable. The ears 322, 324 can be squeezed or moved with the surgical instrument, causing the elastic hinge section 338 of the body 316 to flex and extend the width of the gap 336 and the diameter of the channel 320 (see also Figure 3A-3B 12 ). Once the instrument releases the ears 322, 324, the ferrule 314 transitions back to the position of FIG. 12 due to the elastic nature of the body 316.

[0046] The electrodes 312a, 312b, cuff 314, and gap 336 may be of the same type as described with respect to the previous embodiments and are arranged to provide continued intraoperative monitoring and / or therapeutic stimulation in current and new surgeries that place nerves at risk without requiring additional dissection or necessary wrapping of the electrode assembly 310 substantially around the entire corresponding nerve. The electrode assembly 310 is configured for use with partially dissected nerves, wherein at least about 50% or more of the circumference of the nerve is exposed. Although the electrode assembly 310 may be used with fully dissected nerves, wherein 100% of the circumference of the nerve is exposed, any degree of dissection greater than about 50% of the circumference is suitable.

[0047] In this particular embodiment, the electrode assembly 310 is bipolar and includes a first electrode 312a and a second electrode 312b spaced apart and supported within one or more channels 350a, 350b formed within an ear handle 322. The channels 350a, 350b may have a variety of configurations suitable for maintaining the position of the electrodes 312a, 312b. For example, each channel 350a, 350b may be configured as shown and described above with respect to channel 50. Each electrode 312a, 312b is connected to a corresponding lead assembly 360a, 360b, which may each optionally be configured similar to the lead assembly 60 shown and described herein. The electrode assembly 310 may further optionally include one or more strain reduction features, such as a retaining clip assembly (see with respect to Figure 7The disclosed retaining clip assembly 80 and related disclosure) and / or the band 361 that secures the two lead assemblies 360a, 360b together. It will be apparent in light of this disclosure that the electrode assembly 310 can be configured and function similarly to the other electrode assemblies disclosed above in all other respects not explicitly set forth.

[0048] Figures 13A-14B A self-retaining needle electrode assembly 410 is shown. The electrode assembly 410 includes a first needle electrode 412a and a second needle electrode 412b; wherein the first needle electrode 412a includes a first tip 413a and the second needle electrode 412b includes a second tip 413b. The electrode assembly 410 further includes a body 416 having a first end 416a, a second end 416b, a first side portion 418a, and a second side portion 418b. The body 416 interconnects the first needle electrode 412a and the second needle electrode 412b and includes an articulated section 420 interconnected with the first side portion 418a and the second side portion 418b, and a first piece 422a extending from the first portion 418a and a second piece 422b extending from the second portion 418b.

[0049] like Fig.13A As shown, the body 414 has an inherent arrangement in which the first tip 413a and the second tip 413b are pulled toward each other and the first support block 422a is spaced apart from the second support block 422a. In various embodiments, the articulated section 420 can be made of an elastic (elastomeric) material, such as suggested above with respect to the hoop 14, which allows the first portion 418a and the second portion 418b to move relative to each other (e.g., when the user has not applied an external force to the body 414) Fig. 13B ), and return to Fig.13A The inherent arrangement of Fig.13A In the inherent arrangement of Fig. 13B The first and second portions 418a, 418b are positioned closer to each other at the first end 418a than in the expanded arrangement of FIG. Fig. 13B The body 414 is shown in an expanded arrangement, with the first side portion 418a and the second side portion 418b drawn together at the second end 416b so as to be aligned with the body 414. Fig.13A Compared to the inherent arrangement of the body 414, the first tip 413a and the second tip 413b are positioned farther away from each other. In the deployed arrangement, the support blocks 422a, 422b can optionally be configured to touch each other and prevent over-extension of the first tip 413a and the second tip 413b. As shown, the support blocks 422a, 422b can be positioned proximally relative to the articulated section 420. To use this electrode assembly 410, the first portion 418a and the second portion 418b are pressed toward each other at the second end 416b of the body 414 to increase the distance between the first tip 413a and the second tip 413b, as shown in FIG. Fig. 14B Next, when in the deployed arrangement, the first needle 412a and the second needle 412b are inserted into the tissue T near the nerve N ( Figures 14A-14B ). Next, the first portion 418a and the second portion 418b are loosened to allow the first tip 413a and the second tip 413b to move toward each other and enter Fig.13A The inherent arrangement of the needle electrode assembly 410 engages the nerve N within the tissue T for use. This embodiment is particularly applicable when the nerve N is partially dissected (less than 100%, or even less than 50% of the circumference of the nerve N is exposed).

[0050] In the exemplary embodiment shown, the electrode assembly 410 further includes lead assemblies 460a, 460b interconnecting each respective needle electrode 412a and 412b. FIG. 13A to FIG. 13B As seen in the comparison of FIG. 4 , the first lead component 460a and the second lead component 460b can be moved relative to each other near the second end 416b of the body 414. Each lead component 460a, 460b can be optionally connected to a Figure 7 The fixing clip 80 shown and described provides strain relief. The needle electrode assembly 410 can be monopolar or can be a bipolar configuration. In the bipolar configuration, each needle electrode 412a, 412b will be active, and the lead assembly 460a, 460b will now contain isolated conductors as will be understood by those skilled in the art.

[0051] The various electrode assemblies 10, 110, 210, 310 of the present disclosure can be delivered via a cannula inserted into a skin incision. In some embodiments, the cannula and skin incision are equal to or less than 5 mm. The electrode assembly 10, 110, 210, 310, 410 is connected to the APS, for example, via one or more lead assemblies 60, 460a, 460b.

[0052] Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the present disclosure.

Claims

1. An electrode assembly for receiving a nerve; the electrode assembly comprising: A cuff comprising a body having a first end, a second end and defining a first channel configured to receive the nerve, the cuff further comprising first and second lugs extending radially outward from the body; wherein the second channel is formed in the first lug; wherein the body further defines a gap, and the gap has a variable width and is configured to support a fixed angle less than 360 degrees to the circumference of the nerve; an electrode supported by and positioned within the second channel; as well as a lead assembly interconnecting the electrode and extending within the second passage, wherein the electrode comprises a top portion having a first channel and a second channel; and further wherein the lead assembly is received in the first channel and the second channel of the top portion.

2. The electrode assembly of claim 1, wherein the first and second ear handles each comprise a foot.

3. The electrode assembly of any one of claims 1 to 2, wherein the second channel comprises a conical lead-in feature.

4. The electrode assembly according to any one of claims 1 to 2, wherein the first and second ear handles are interconnected by a hinge section so that the distance between the first and second ear handles is variable. The electrode assembly of claim 4 , wherein the hinge segment is made of an elastomeric material.

6. The electrode assembly of claim 4, wherein changing the distance between the first and second earstem changes the width of the gap accordingly.

7. The electrode assembly according to any one of claims 1 to 2, wherein the gap is non-linear.

8. The electrode assembly according to any one of claims 1 to 2, wherein the first and second ears are configured identically.

9. The electrode assembly of any one of claims 1 to 2, wherein the first and second ears have a textured surface.

10. The electrode assembly of any one of claims 1-2, wherein the first and second ears extend radially outward from the first channel.

11. The electrode assembly according to any one of claims 1 to 2, wherein the width of the gap is uniform.

12. The electrode assembly of any one of claims 1 to 2, further comprising a second electrode positioned within the cuff.

13. The electrode assembly of claim 12, wherein the second electrode is positioned within the first ear handle.

14. The electrode assembly according to any one of claims 1 to 2, wherein the body has a semicircular cross-section at each of the first and second ends.

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